Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO

NCT06910163 | Not Yet Recruiting FDA Device

• 1 other identifier: 2410303013
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

Direct-to-angio approach from loCal hOspitals based on a PoInt-of-care bLOod Test for LVO (COPILOT) is a multi-center, prospective, cluster-randomized crossover trial that will evaluate if the triage assessment to thrombectomy puncture time is shorter after performing the LVOne testing compared to current management standards in patients with suspected large vessel occlusion.

Conditions

Acute Stroke

Keywords

Acute Stroke; Ischemic Stroke; LVOne Test; Diagnosis; Large Vessel Occlusion (LVO); Glial Fibrillary Acidic Protein (GFAP); D-dimer

Outcome Measures

Primary Outcomes (1)

• Change in the time from triage assessment to thrombectomy puncture

  The difference in time from the participant triage assessment to thrombectomy puncture.

  24 hours

Secondary Outcomes (9)

• Time from spoke hospital triage assessment to LVOne test in intervention

  24 hours

• Time from HUB hospital triage assessment to LVOne test in intervention

  24 hours

• Time from HUB hospital triage assessment to thrombectomy puncture

  24 hours

• Thrombectomy rate (proportion of treated LVO)

  24 hours

• Length of hospital stay

  From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 30 days

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Participants will receive the current diagnostic standard of care.

Diagnostic Test: Diagnostic standard of care

LVOne Test

EXPERIMENTAL

Participants will receive the LVOne test alongside the current standard of care.

Diagnostic Test: Diagnostic standard of care; Diagnostic Test: LVOne Test

Interventions

Diagnostic standard of care DIAGNOSTIC_TEST

Participants will receive the diagnostic standard of care: standard laboratory workup, non-contrast brain CT, brain CTA, brain CTP, or brain MRI.

LVOne Test; Standard of Care

LVOne Test DIAGNOSTIC_TEST

Participants will receive the LVOne test, which will measure D-dimer and Glial Fibrillary Acidic Protein (GFAP) levels to diagnose acute stroke.

LVOne Test

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 21 to 85 years old
• Language: Speak and understand Spanish or English
• Residence: Resident of Puerto Rico
• Clinical presentation: Suspected acute stroke
• Time of presentation: Monday to Friday, between 8:00 a.m. and 4:00 p.m.
• Time of symptom onset: symptoms are known to have begun within the last 6 hours, OR last known to be well between 6 and 18 hours ago, confirmed by a reliable witness or healthcare professional

You may not qualify if:

• Previous healthcare encounter:
• Already assessed at another hospital, and ambulance admission is a transfer for continuing care OR
• Received thrombolysis therapy before consent (e.g., tPA, alteplase)
• Medical History: diagnosed with any of the following in the past 4 weeks: deep vein thrombosis (DVT), pulmonary embolism (PE), arterial embolism, stroke, transient ischemic attack (TIA), long bone fracture, major trauma, surgery under general anesthesia, or head injury requiring hospital admission within the last 4 weeks.
• Modified Rankin Scale: Pre-stroke mRS ≥ 3
• The patient is a pregnant woman
• The patient is under legal custody or deprived of liberty in penitentiary institutions
• The patient is unable to provide informed consent on their own and whose authorized legal representatives are unavailable in person or by telephone during recruitment

Sponsors & Collaborators

• Juan Vicenty: lead
• University of Puerto Rico: collaborator
• Mennonite Health System: collaborator

Study Sites (1)

Hospital Menonita Caguas

Caguas, PR, 00725, Puerto Rico

Location

Related Publications (12)

• Malhotra K, Gornbein J, Saver JL. Ischemic Strokes Due to Large-Vessel Occlusions Contribute Disproportionately to Stroke-Related Dependence and Death: A Review. Front Neurol. 2017 Nov 30;8:651. doi: 10.3389/fneur.2017.00651. eCollection 2017.

  PMID: 29250029 BACKGROUND

• Victor P, Bian E, Mamdouh H, Mohamed GA, Nour HA, Miller K, Singh K, Patel S, Segovis C, Nahab F. Upfront vascular imaging in acute stroke: Impact on thrombectomy transfer time at a primary stroke center. J Stroke Cerebrovasc Dis. 2024 Aug;33(8):107815. doi: 10.1016/j.jstrokecerebrovasdis.2024.107815. Epub 2024 Jun 13.

  PMID: 38878844 BACKGROUND

• Saver JL. Time is brain--quantified. Stroke. 2006 Jan;37(1):263-6. doi: 10.1161/01.STR.0000196957.55928.ab. Epub 2005 Dec 8.

  PMID: 16339467 BACKGROUND

• Durrani Y, Gerstl JVE, Murphy D, et al. Prospective Validation of Glial Fibrillary Acidic Protein, d -Dimer, and Clinical Scales for Acute Large-Vessel Occlusion Ischemic Stroke Detection . Stroke: Vascular and Interventional Neurology. Published online May 17, 2024. doi:10.1161/svin.123.001304

  BACKGROUND

• Gaude E, Nogueira B, Ladreda Mochales M, Graham S, Smith S, Shaw L, Graziadio S, Ladreda Mochales G, Sloan P, Bernstock JD, Shekhar S, Gropen TI, Price CI. A Novel Combination of Blood Biomarkers and Clinical Stroke Scales Facilitates Detection of Large Vessel Occlusion Ischemic Strokes. Diagnostics (Basel). 2021 Jun 22;11(7):1137. doi: 10.3390/diagnostics11071137.

  PMID: 34206615 BACKGROUND

• Kothari RU, Brott T, Broderick JP, Barsan WG, Sauerbeck LR, Zuccarello M, Khoury J. The ABCs of measuring intracerebral hemorrhage volumes. Stroke. 1996 Aug;27(8):1304-5. doi: 10.1161/01.str.27.8.1304.

  PMID: 8711791 BACKGROUND

• Puetz V, Dzialowski I, Hill MD, Subramaniam S, Sylaja PN, Krol A, O'Reilly C, Hudon ME, Hu WY, Coutts SB, Barber PA, Watson T, Roy J, Demchuk AM; Calgary CTA Study Group. Intracranial thrombus extent predicts clinical outcome, final infarct size and hemorrhagic transformation in ischemic stroke: the clot burden score. Int J Stroke. 2008 Nov;3(4):230-6. doi: 10.1111/j.1747-4949.2008.00221.x.

  PMID: 18811738 BACKGROUND

• Bamford J. Clinical examination in diagnosis and subclassification of stroke. Lancet. 1992 Feb 15;339(8790):400-2. doi: 10.1016/0140-6736(92)90085-h. No abstract available.

  PMID: 1346666 BACKGROUND

• van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. doi: 10.1161/01.str.19.5.604.

  PMID: 3363593 BACKGROUND

• Barber PA, Demchuk AM, Zhang J, Buchan AM. Validity and reliability of a quantitative computed tomography score in predicting outcome of hyperacute stroke before thrombolytic therapy. ASPECTS Study Group. Alberta Stroke Programme Early CT Score. Lancet. 2000 May 13;355(9216):1670-4. doi: 10.1016/s0140-6736(00)02237-6.

  PMID: 10905241 BACKGROUND

• Goyal M, Fargen KM, Turk AS, Mocco J, Liebeskind DS, Frei D, Demchuk AM. 2C or not 2C: defining an improved revascularization grading scale and the need for standardization of angiography outcomes in stroke trials. J Neurointerv Surg. 2014 Mar;6(2):83-6. doi: 10.1136/neurintsurg-2013-010665. Epub 2013 Feb 6. No abstract available.

  PMID: 23390038 BACKGROUND

• Menon BK, Smith EE, Modi J, Patel SK, Bhatia R, Watson TW, Hill MD, Demchuk AM, Goyal M. Regional leptomeningeal score on CT angiography predicts clinical and imaging outcomes in patients with acute anterior circulation occlusions. AJNR Am J Neuroradiol. 2011 Oct;32(9):1640-5. doi: 10.3174/ajnr.A2564. Epub 2011 Jul 28.

  PMID: 21799045 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan C Vicenty Padilla, MD

  University of Puerto Rico Medical Sciences Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria M Garcia Perez

CONTACT

939-417-4432; dra.garcia.neurosx@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The neuro-radiologist(s) who will read patient brain imaging and the expert stroke clinician(s) who will assign a clinical outcome (reference standard) will be blinded to the LVOne test results. Due to the nature of the LVOne and the management implications of a positive test, hospital clinicians will not be blinded to these results.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: The COPILOT trial, a cluster randomized crossover study within the Sistema de Salud Menonita (SSM) hospital network, evaluates whether early detection of large vessel occlusion (LVO) stroke via a novel blood test accelerates triage-to-thrombectomy time. Phase 0 (3 months): Baseline data collection to establish pre-intervention comparisons. Patients receive standard care, and an interim analysis assesses recruitment and study power. Phase 1 (12 months): Clusters are randomized to intervention (LVOne test) or control (standard care). Analysts remain blinded, and interim analysis reassesses recruitment and primary outcomes. Phase 2 (12 months): Clusters switch roles, enabling within-cluster comparisons. Due to the intervention's nature, participants and staff cannot be blinded.

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 4, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)